Colorectal Cancer
Conditions
Keywords
Nutrition
Brief summary
This study uses the opinions of adults between the ages of 45 and 73 years old to develop and test an interactive nutrition module for use in an existing colorectal cancer screening intervention using virtual human technology. The main questions answered include: * What content do adults want to receive from a web-based interaction about colorectal cancer screening and nutritional risks for colorectal cancer? * Does a brief interaction with a virtual human delivering tailored cancer prevention information impact cancer prevention intentions and attitudes among a national sample of geographically rural U.S. adults? This study will contribute to knowledge of what messages and graphics promote understanding of cancer risk and promote screening with the potential to promote behaviors that reduce cancer risk.
Detailed description
The study occurred in two phases. Phase one was a qualitative aim that collected feedback from participants in iterative cycles of focus groups and individual think-aloud interviews. Phase one feedback was analyzed and applied to develop a tailored, web-based prototype that addressed participant desires for an intervention to address colorectal cancer prevention and nutrition risk education. The prototype was a brief conversation delivered by an interactive Virtual Health Assistant (virtual character with audio and visual elements that mimic a conversation with a human).
Interventions
OTHERvirtual technology - high interactive
Participants engage with web-based cancer prevention content and answer a short series of questions designed to assess their baseline risk for colon cancer and dietary intake. Interactive nutrition risk feedback will be customized based on user input.
OTHERvirtual technology - low interactive
Participants engage with web-based cancer prevention content and answer a short series of questions designed to assess their baseline risk for colon cancer. Minimally interactive risk feedback will be delivered.
OTHERnon-colorectal cancer related module
Participants engage with web-based content not related to colorectal cancer or nutrition.
Sponsors
National Cancer Institute (NCI)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 73 Years
Healthy volunteers
Yes
Inclusion criteria
* Eligible adults will be between 45 -73 years old, * Proficient in English and * Geographically residing in rural areas (based on zip code) * Identify as Black or White racial identity Exclusion: * Completed a colonoscopy in the past 10 years * Completed a sigmoidoscopy in the past 5 years * Completed a home stool test in the past 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk Perceptions for Colorectal Cancer | up to 2 hours | Items measured on a 7-point Likert scale, (e.g. My chances of getting colorectal cancer are high), where 1 is strongly disagree and 7 is strongly agree. |
| Intentions to Screen for Colorectal Cancer | up to 2 hours | Two individual items assessed intentions to screen: 1. A single item measured intentions to screen for colorectal cancer (readiness to screen) adapted from (Boonyasiriwat, Hung, Hon, et. al, 2014.) Participants answer the following prompt: Please indicate what best represents your plans for colorectal cancer screening. Response options str: 1 point = I am not planning to screen in the next 6 months; 2 points = I am thinking about screen, but not in the next 6 months; 3 points = I am considering screening in the next 6 months and 4 points for = I am already taking steps to screen in the next 6 months. Higher scores =higher readiness to screen (better outcome). Min. score = 1 ; Max. score =4. 2. a single item assessed intentions on a Likert Scale. Question: I want to get screened for colorectal cancer where: 1 = strongly disagree-7 = strongly agree). Min. score = 1 - Max. score is 7. Higher scores indicate a stronger desire to obtain screening (better outcome). |
| Information Seeking Behavior | up to 2 hours | Does participant click on link to more information. The survey platforms event tracking feature will be used to track clicks (yes/no) for more information. |
Countries
United States
Participant flow
Recruitment details
Aim 2 Pilot Test: Web-based, single-interaction, intervention Aim 2 intervention development (focus groups and interviews)
Pre-assignment details
Total N =139 (Aim 1 = 48; Aim 2 = 91) AIMS 1 & 2 are independent. Aim 1 participants did NOT complete Aim 2. (AIM 2) Qualtrics panels recruited a national sample of (n=91) rural adults. Respondents from this national sample who did not meet the qualifying criteria were screened out by the Qualtrics platform and did not get randomized to one of the 3 arms of the web-based, intervention. ( AIM 1) participants (n=48) completed focus groups/interviews informing intervention content.
Participants by arm
| Arm | Count |
|---|---|
| Aim 2 Web-based Pilot Test: Control participants interact with attention control information about clinical trials (not focused on cancer, not focused on nutrition) | 25 |
| Aim 2 Web-based Pilot Test: Low Interactive Condition Participants interact with nutrition and cancer risk information in a low interactive condition. | 35 |
| Aim 2 Web-based Pilot Test: VHA High Interactive Condition Participants interact with nutrition and cancer risk information delivered by a Virtual Health Assistant in a high interactive condition. | 31 |
| Aim 1: Focus Group and Interviews Participants provided feedback to inform the web-based intervention that would be pilot-tested in Aim 2. | 48 |
| Total | 139 |
Baseline characteristics
| Characteristic | Aim 2 Web-based Pilot Test: Low Interactive Condition | Aim 2 Web-based Pilot Test: VHA High Interactive Condition | Aim 1: Focus Group and Interviews | Total | Aim 2 Web-based Pilot Test: Control |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 8 Participants | 17 Participants | 32 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 23 Participants | 31 Participants | 107 Participants | 21 Participants |
| Age, Continuous | 55.1 years STANDARD_DEVIATION 7.7 | 57 years STANDARD_DEVIATION 9.2 | 61.7 years STANDARD_DEVIATION 7 | 56 years STANDARD_DEVIATION 8.3 | 56 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 29 Participants | 48 Participants | 136 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 13 Participants | 31 Participants | 71 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 18 Participants | 17 Participants | 68 Participants | 13 Participants |
| Region of Enrollment United States | 35 participants | 31 participants | 48 participants | 91 participants | 25 participants |
| Sex: Female, Male Female | 24 Participants | 21 Participants | 24 Participants | 85 Participants | 16 Participants |
| Sex: Female, Male Male | 11 Participants | 10 Participants | 24 Participants | 54 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Information Seeking Behavior
Does participant click on link to more information. The survey platforms event tracking feature will be used to track clicks (yes/no) for more information.
Time frame: up to 2 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Aim 2 Web-based Pilot Test: Control | Information Seeking Behavior | No | 11 Participants |
| Aim 2 Web-based Pilot Test: Control | Information Seeking Behavior | Yes | 14 Participants |
| Aim 2 Web-based Pilot Test: Low Interactive Condition | Information Seeking Behavior | No | 14 Participants |
| Aim 2 Web-based Pilot Test: Low Interactive Condition | Information Seeking Behavior | Yes | 21 Participants |
| Aim 2 Web-based Pilot Test: VHA High Interactive Condition | Information Seeking Behavior | No | 14 Participants |
| Aim 2 Web-based Pilot Test: VHA High Interactive Condition | Information Seeking Behavior | Yes | 17 Participants |
Primary
Intentions to Screen for Colorectal Cancer
Two individual items assessed intentions to screen: 1. A single item measured intentions to screen for colorectal cancer (readiness to screen) adapted from (Boonyasiriwat, Hung, Hon, et. al, 2014.) Participants answer the following prompt: Please indicate what best represents your plans for colorectal cancer screening. Response options str: 1 point = I am not planning to screen in the next 6 months; 2 points = I am thinking about screen, but not in the next 6 months; 3 points = I am considering screening in the next 6 months and 4 points for = I am already taking steps to screen in the next 6 months. Higher scores =higher readiness to screen (better outcome). Min. score = 1 ; Max. score =4. 2. a single item assessed intentions on a Likert Scale. Question: I want to get screened for colorectal cancer where: 1 = strongly disagree-7 = strongly agree). Min. score = 1 - Max. score is 7. Higher scores indicate a stronger desire to obtain screening (better outcome).
Time frame: up to 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aim 2 Web-based Pilot Test: Control | Intentions to Screen for Colorectal Cancer | 4 point, 6-month readiness | 2.6 score on a scale | Standard Deviation 1 |
| Aim 2 Web-based Pilot Test: Control | Intentions to Screen for Colorectal Cancer | 7-point Likert Intention | 5 score on a scale | Standard Deviation 1.6 |
| Aim 2 Web-based Pilot Test: Low Interactive Condition | Intentions to Screen for Colorectal Cancer | 4 point, 6-month readiness | 2.5 score on a scale | Standard Deviation 1 |
| Aim 2 Web-based Pilot Test: Low Interactive Condition | Intentions to Screen for Colorectal Cancer | 7-point Likert Intention | 4.9 score on a scale | Standard Deviation 2 |
| Aim 2 Web-based Pilot Test: VHA High Interactive Condition | Intentions to Screen for Colorectal Cancer | 4 point, 6-month readiness | 2.5 score on a scale | Standard Deviation 0.8 |
| Aim 2 Web-based Pilot Test: VHA High Interactive Condition | Intentions to Screen for Colorectal Cancer | 7-point Likert Intention | 5.2 score on a scale | Standard Deviation 1.4 |
Primary
Risk Perceptions for Colorectal Cancer
Items measured on a 7-point Likert scale, (e.g. My chances of getting colorectal cancer are high), where 1 is strongly disagree and 7 is strongly agree.
Time frame: up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aim 2 Web-based Pilot Test: Control | Risk Perceptions for Colorectal Cancer | 3.3 score on a scale | Standard Deviation 1.5 |
| Aim 2 Web-based Pilot Test: Low Interactive Condition | Risk Perceptions for Colorectal Cancer | 3.6 score on a scale | Standard Deviation 1.4 |
| Aim 2 Web-based Pilot Test: VHA High Interactive Condition | Risk Perceptions for Colorectal Cancer | 3.5 score on a scale | Standard Deviation 1.3 |